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MEDICAL MARIJUANA ADVISORY BOARD MEETING
* * * * * * * * *
BEFORE: RACHEL LEVINE, M.D., Chair
Lt. Col. Robert Evanchick, Member
Janet Getzy Hart, R.Ph., Member
Kalonji Johnson, Member
Sarah Boateng, Member
Scott L. Bohn, Member (via phone)
Molly Robertson, Member
Jennifer Shuckrow, Member (via phone)
I. William Goldfarb, M.D., Member (via
phone)
Shalawn James, Member
Luke Shultz, Member
HEARING: Wednesday, November 13, 2019
10:00 a.m.
LOCATION: Keystone Building Meeting Center
Forest Room
Suite 114 East
400 North Street
Harrisburg, PA 17120
Reporter: Michael G. Sargent, CVR
Any reproduction of this transcript
is prohibited without authorization
by the certifying agency.
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ALSO PRESENT: Patrick Nightingale, Esquire, 1
Dr. Marina Goldman, Dr. Andrew Peterson, John 2
Collins 3
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I N D E X 1
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DISCUSSION AMONG PARTIES 5 - 9 3
PRESENTATION 4
By Patrick Nightingale 9 - 14 5
PRESENTATION 6
By Dr. Andrew Peterson 15 - 19 7
DISCUSSION AMONG PARTIES 19 - 21 8
PRESENTATION 9
By Dr. Marina Goldman 21 - 26 10
DISCUSSION AMONG PARTIES 26 - 68 11
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P R O C E E D I N G S 1
---------------------------------------------------- 2
CHAIR: All right. 3
It is 10:00 a.m. and we have a quorum. 4
So at this time I would like to call the meeting to 5
order. 6
This is the Medical Marijuana Advisory 7
Board Meeting. And it is now 10:00 a.m. on 8
Wednesday, November 13th, 2019. 9
I'd like to start in terms of our roll 10
call about. Those on the phone. 11
So Dr. William Goldfarb, are you on 12
the phone? Dr. Goldfarb, you might be muted. 13
DR. GOLDFARB: Yes. 14
CHAIR: Thank you. 15
DR. GOLDFARB: Yes. 16
CHAIR: And - and Jennifer Shuckrow 17
are you on the phone? Are you muted, Jennifer? 18
Jennifer Shuckrow, are you on the 19
phone? We heard you before. 20
MS. SHUCKROW: I'm - I'm here. 21
CHAIR: Great. Thank you. 22
And we also were expecting Scott Bohn, 23
Chief, West Chester Police Department. 24
Sir, are you on the phone? Chief 25
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Bohn, are you on the phone? I know that rhymes, but 1
- okay. So not yet. 2
So now let's take a roll call. We 3
know that District Attorney Ray Tonkin, Dr. William 4
Trescher and Dr. Lanie Francis will not be available 5
today. 6
So Rachel Levine is here. 7
Lieutenant Colonel Robert Evanchick? 8
MR. EVANCHICK: Present. 9
CHAIR: Janet Getzy Hart? 10
MS. GETZY HART: Present. 11
CHAIR: Kalonji Johnson? Not here 12
yet. 13
CHAIR: Sarah Boateng? 14
MS. BOATENG: Present. 15
CHAIR: Molly Robertson? 16
MS. ROBERTSON: Here. 17
CHAIR: Shalawn James? 18
MS. JAMES: Present. 19
CHAIR: Luke Shultz? 20
MR. SHULTZ: Present. 21
CHAIR: Did I miss anybody? 22
Anybody else on the phone? All right. 23
Well, we do have a quorum. Am I 24
correct? 25
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BOARD MEMBER: Yes. So we - so we can 1
do business. 2
CHAIR: All right. 3
So the first order of business is we 4
would like to approve the minutes from our Medical 5
Marijuana Advisory Board Meeting on August 14th, 6
2019. 7
May I have a motion to approve the 8
minutes? 9
MS. JAMES: Motion to approve. 10
CHAIR: Thank you. 11
May I have a second? 12
MS. ROBERTSON: Second. 13
CHAIR: Okay. 14
And all in favor say aye. 15
AYES RESPOND 16
CHAIR: Aye. 17
On the phone? 18
MS. SHUCKROW: Aye. Aye. 19
CHAIR: Okay. 20
And do any say nay? Any abstentions? 21
All right. So the meetings (sic) are 22
approved. 23
So we'd like to start today's meeting 24
by hearing from a number of speakers that have been 25
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invited today to address the Board. 1
Thank you all very much for coming. 2
One speaker is still not here yet, but we'll see if 3
she's able to come. I wanted to remind our speakers 4
that they have five minutes to speak. And so given 5
those time limitations we won't be having questions 6
or - basically you're addressing the Board. 7
Sunny Horvath will raise her hand when 8
you have one minute remaining. She'll raise her 9
hand in the completion of the five minutes. You 10
know if you're finishing a sentence, I'll let you 11
finish the sentence, so don't worry about it, but - 12
but please don't go on -. 13
And the first speaker today is Mr. 14
Patrick Nightingale, an attorney from Allegheny 15
County, to speak about challenges facing the medical 16
marijuana system and patients and the criminal 17
justice system. 18
Mr. Nightingale? 19
ATTORNEY NIGHTINGALE: Thank you. 20
Thank you for giving - oh, wait. 21
What -? 22
CHAIR: Well, that way they'll be able 23
to hear you on the phone. 24
ATTORNEY NIGHTINGALE: Hopefully it's 25
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not counting against my five minutes. I'm moving a 1
little slow. 2
CHAIR: No. No, you're okay. It's 3
all right. It's all right. 4
ATTORNEY NIGHTINGALE: I'll reset my 5
phone. 6
CHAIR: Yeah. Yeah. Reset your 7
timer. We're all good. 8
ATTORNEY NIGHTINGALE: Thank you for 9
giving me the opportunity to address the Board this 10
morning. My name is Patrick Nightingale. I'm an 11
attorney from Pittsburgh and the Director of the 12
Pittsburgh chapter of the National Organization for 13
the Reform of Marijuana Laws also known as NORMAL. 14
I will take this opportunity to address a few issues 15
that directly impact Pennsylvania's growing medical 16
cannabis patient community. 17
As both a criminal defense attorney 18
and reform activist, I continually - continually 19
experience what I call a lack of law-enforcement 20
education regarding patient rights and what 21
constitutes a legal medical cannabis product. 22
Officers often do not know that dry leaf is legal or 23
that patients may possess paraphernalia needed to 24
consume medical cannabis products. Even Prosecutors 25
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and Judges are unaware of the specifics of the 1
program. The patient community suffers when law 2
enforcement file charges and seize products out of a 3
lack of education of the program. 4
We implore the Advisory Board to 5
recommend to the Department of Health that it lead 6
the effort to educate. This is simply too big a 7
task to outsource to nonprofit organizations such as 8
NORMAL and Keystone Cannabis Coalition or even to 9
our license holders. 10
Additionally, I do not believe that 11
law enforcement will be receptive to being educated 12
by activists from NORMAL or other cannabis reform 13
organizations. The Department could, for example, 14
enlist the - the support of the Attorney General's 15
Office as Attorney General Shapiro is on record 16
supporting full legalization. 17
Similarly, I urge the Board to 18
recommend that the Department spearhead a patient 19
educational forum or host a series of webinars that 20
address patients' rights, risks and 21
responsibilities. Patients do not know, for 22
example, the risk of DUI prosecution under 23
Pennsylvania's Zero Tolerance DUI statute regarding 24
cannabis. Pennsylvania's patients need to know that 25
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Pennsylvania's Implied Consent Law means they cannot 1
refuse a chemical test request from a police 2
officer. Patients do not know that smoking is 3
prohibited or that smoking paraphernalia, such as a 4
bowl, a blunt or a bong remains a misdemeanor-level 5
offense. 6
The Employment Antidiscrimination 7
Provisions of our law do not offer blanket 8
protections. Patients in public housing have faced 9
eviction and have been forced to cease medical 10
cannabis use. The Supremacy Clause causes 11
Pennsylvania patients to lose valuable Second 12
Amendment rights, as the federal government does not 13
recognize medical cannabis. 14
Many have surrendered their patient 15
identification as a result. Others risk violating 16
Pennsylvania law by failing to disclose patient 17
status when applying for a Conceal to Carry Permit 18
or a new firearm purchase. As with law-enforcement 19
education this task is simply too great for 20
volunteers and nonprofits. We need the Department's 21
help. 22
I know there is some question as to 23
whether the Advisory Board retains its authority in 24
making recommendations to the Department of Health, 25
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considering the final report, which was submitted in 1
May of 2018. I would submit that Section 1201, 2
Subsection G of the Act provides for the appointment 3
of Board Members for two, three and four-year terms. 4
And that demonstrates legislative intent that the 5
Board remain viable and retain its authority to make 6
recommendations to the Department of Health beyond 7
recommending new qualifying conditions. 8
Product costs remain a very serious 9
issue for patients, especially patients of limited 10
means. Patients are very appreciative that 11
dispensaries can offer discounts, including customer 12
loyalty discounts. 13
I urge the Advisory Board to recommend 14
that the Department of Health conduct cost analysis 15
of other medical cannabis states pursuant to Section 16
705 of the Act, with a focus on states where 17
Pennsylvania cultivation license holders are 18
operational. The Department will see that 19
Pennsylvania's retail medical cannabis prices are 20
significantly higher than states such as Michigan, 21
Colorado, Oregon, California, et cetera. 22
The Department has within its 23
authority to impose price caps pursuant to Section 24
705. Pennsylvania patients should not face a 300 25
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percent retail markup because license holders are 1
trying to recoup their investor's dollars as quickly 2
as possible. 3
I also ask that the patient (sic) 4
recommends to the Department that the Indigent 5
Patient Access Fund be made a priority immediately, 6
even if the startup costs of the program have not 7
been fully repaid. Patients of limited means need 8
help now. 9
Patients have become very good at 10
finding the particular product or strain that is 11
effective for them. Not having access to the 12
product because of product shortages can have a 13
serious effect on patient treatment. 14
I ask the Advisory Board to urge the 15
Department of Health to use whatever means within 16
its power, including the threat of revoking 17
licenses, if cultivation license holders do not meet 18
their operational time tables as they said they 19
would in their license applications. The license 20
holders who are shipping product are under great 21
pressure to meet demands of the growing patient 22
community. This has resulted in some rushing flower 23
to marker and/or reducing product availability. 24
Therefore I ask that the Board 25
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consider recommending to the Department that it add 1
cultivation licenses, as it is authorized to do 2
pursuant to Section 616 and 1201(j). 3
Finally, I ask that the Board 4
recommend to the Department of Health that it work 5
with the legislature to introduce legislation that 6
protects patients from Pennsylvania's Zero Tolerance 7
DUI laws regarding cannabis metabolites and to treat 8
medical cannabis similarly to a schedule II 9
controlled substance requiring actual proof of 10
impairment. Thank you for this opportunity. 11
CHAIR: Thank you very much. 12
That was quite impressive. Thank you 13
very much for - for your comments. And I know it 14
was challenge to get everything in, in the time. 15
Thank you so much. 16
ATTORNEY NIGHTINGALE: Thank you, 17
Doctor. 18
CHAIR: I appreciate your being here. 19
Now, Dr. Goldman? I don't see her. 20
Okay. So we're going to move one. 21
Dr. Andrew Peterson, who is here to 22
talk about medical marijuana package and labeling. 23
Dr. Goldman? All right. Well - well, 24
why don't - why don't you catch your breath and 25
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everything. That's fine. Thank you for being here. 1
Dr. Peterson will speak and then you will speak. 2
Okay? 3
DR. PETERSON: Sure. Okay. Thank 4
you, Secretary Levine and distinguished Board 5
Members. My name is Andrew Peterson. I'm a 6
Professor of Clinical Pharmacy and Professor of 7
Health Policy at the University of the Sciences in 8
Philadelphia. And I also serve as the Executive 9
Director of the Substances Abuse Disorders 10
Institute. 11
I'm here today to bring forward some 12
concerns regarding the labeling standards and 13
practices currently in place in the Pennsylvania 14
Medical Marijuana Program. As you may know, a 15
recent letter to the editor of the New England 16
Journal of Medicine described a case of a 17
Pennsylvania resident being hospitalized because 18
they received too much THC from a liquid marijuana 19
product. The authors of this case highlighted the 20
need for the standardization of medical marijuana 21
products so end users can use them safely. Proper 22
labeling, both under primary and extended labels, is 23
part of that standardization. 24
I have a few examples that I'd like to 25
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share with you, to show how labeling in the 1
Commonwealth can be confusing and potentially create 2
medication errors and jeopardize the safety of those 3
patients. 4
I'd like you to pass some exhibits, if 5
you don't mind. 6
If you take a look on Exhibit 1, we 7
have the Pennsylvania's label - label is put on two 8
boxes. The box is on the left labeled Bio-Jesus box 9
notes it contains 500 milligrams both on the box and 10
the Pennsylvania label, but of what? It's not clear 11
on that label. 12
Similarly the box on the right, 13
labeled Harlequin, also says 500 milligrams, but the 14
box has, in big letters, CBD written across. One 15
would presume that this contains only CBD, since 16
there is no other indication anywhere about it. 17
Except if you look at the Pennsylvania label, which 18
is placed on there, which says that it is one to one 19
Harlequin 500 milligrams. 20
And the average consumer would then 21
presume that it might be 500 milligram, 200 22
milligram - 250 milligrams of THC and 250 milligrams 23
of CBD or is it 500 milligrams of each? In this 24
particular case the labeling is not clear. 25
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A further example is shown in Exhibit 1
2. Turn the page. There is no standardization with 2
respect to the labeling of the ratio of THC to CBD. 3
On the top we see a tincture with a label of THC to 4
CBD of one to ten, and on the bottom we see a CBD to 5
THC level of ten to one. Essentially the same 6
product, but the typical consumer may not know that. 7
And this type of unstandardized labeling across 8
manufacturers, grower/processors can certainly lead 9
to medication errors and even overmedicating. 10
Lastly, if you would take a look at 11
Exhibit 3 and take a look at the cartridges that 12
were removed from those same boxes. These 13
cartridges are indistinguishable from one another, 14
yet they are two different products. If a consumer 15
removed both of them from their respective cartridge 16
- packages there exists a possibility that they 17
could be mixed up and misused, thus potentially 18
resulting in a medication error and potential 19
consequences like those seen in the case report 20
noted earlier. 21
With the goal of improving care and 22
safety for patients using medical - cannabis to 23
treat their health conditions, the Substances Abuse 24
Disorders Institute organized a series of meetings 25
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to discuss the labeling of medical cannabis products 1
provided to the citizens of the Commonwealth. 2
During these three meetings, more than 30 advisors, 3
representing cannabis growers and processors, 4
dispensaries, academia, healthcare providers, the 5
Patient Safety Organization, labeling professionals 6
within the pharmaceutical industries and other 7
medical cannabis-related industries identified 8
specific issues related to the labeling of medical 9
cannabis products and provided suggestions to 10
address the areas of concern. 11
The outcome of these meetings and 12
multiple e-mail communication is this report. Holly 13
has a copy of that report and will provide an 14
electronic version of that to you. 15
I encourage you to read the full 16
report, paying particular attention to Appendix E, 17
where we propose 14 general, 9 specific and 4 18
extended labeling recommendation. 19
For time's sake I will highlight my 20
top four. All products containing THC should bear 21
the statement, this product contains THC and has the 22
potential for mind-altering events on the primary 23
label. For all products containing both THC and 24
CBD, the exact ratio with a grower's process specs 25
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must be reported using the THC to CBD format. 1
The immediate container must be the - 2
the third one. It has to be labeled with the drug 3
name, strength, manufacturer and batch number. 4
And finally the content, THC to CBD, 5
needs to be on the inner products not just on the 6
box in which it is packaged. 7
We believe that these recommendations 8
and the one provided in the report will improve the 9
quality of the labeling and thus reduce the risk of 10
medication errors and, therefore, improve the safety 11
and quality of care for the citizens of the 12
Commonwealth. 13
Marijuana Board, Secretary Levine, I 14
want to thank you for giving me the time today to 15
review our report with you. I want to emphasize the 16
Substances Abuse Disorders Institute is here to help 17
in any way we can to improve the use of medical 18
cannabis in the Commonwealth of Pennsylvania. Thank 19
you. 20
CHAIR: Dr. Peterson, thank you so 21
much for your very - very important presentation. 22
We appreciate it very much. 23
DR. PETERSON: Thank you. 24
CHAIR: Dr. Goldman, are you cool? 25
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DR. GOLDMAN: Yes, thank you. 1
CHAIR: Yeah. Do you need some water 2
or something or are you good? 3
DR. GOLDMAN: I'm good. 4
CHAIR: You're good. All right. 5
What I reminded all the speakers 6
before is that there's a five minute time limit -. 7
DR. GOLDFARB: Can't hear. 8
CHAIR: Okay. 9
BOARD MEMBER: One more on the phone 10
now. 11
CHAIR: Huh? 12
BOARD MEMBER: I think we have one 13
more on the phone. 14
CHAIR: Do we have another person on 15
the phone now? Chief Bohn? 16
DR. GOLDFARB: Cannot hear. 17
BOARD MEMBER: Hello, (610) 436-1324. 18
What's your name who just joined us? 19
CHAIR: Ask if it's Chief Bohn. 20
BOARD MEMBER: Chief Bohn, is that 21
you? 22
CHAIR: Chief Bohn, are you on the 23
phone? If you are, you're muted? 24
CHIEF BOHN: I am. Thank you. 25
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CHAIR: All right. Thank you very 1
much for joining us. 2
We'll try to - to make sure that all 3
the comments are - are able to be heard from the 4
phone. 5
So Dr. Goldman, thank you very much. 6
I think you understand the five minutes and that 7
we're not taking questions, so it's just a 8
presentation. Thank you very much for coming. 9
DR. GOLDMAN: Thank you for giving me 10
this opportunity to address the Board today. 11
I would like to start with an 12
introduction of who we are. I'm a psychiatrist with 13
additional Board Certification in Addiction 14
Psychiatry. I'm a member of the American 15
Psychiatric Association and the American Academy of 16
Addiction Psychiatry. 17
I'm speaking on behalf of the 18
Pennsylvania Psychiatric Society, which is the local 19
branch of the American Psychiatric Association. 20
The Pennsylvania Psychiatric Society 21
initiated the petition I am discussing today. The 22
petition is supported by the Foundation of the 23
Pennsylvania Medical Society, the American Academy 24
of Addiction Psychiatry, the Regional Council of 25
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Child and Adolescent Psychiatry of Eastern 1
Pennsylvania and Southern New Jersey, the drug and 2
alcohol service providers of Pennsylvania, the 3
Pennsylvania State Coroners Association, the 4
Pennsylvania Recovery Alliance and Dr. Jennifer 5
Zampogna, from the Pennsylvania Advisory Council on 6
Drug and Alcohol Abuse. 7
Additionally the American Society of - 8
Addiction Medicine collaborated on this petition by 9
granting us permission to use their letter as the 10
body of our petition. 11
Combined these organizations, the APA, 12
the AAAP, the Council of Child and Adolescent 13
Psychiatry and ASAM comprise, both at the local and 14
national levels, the vast majority of experts in the 15
field of the addiction and addiction psychiatry, 16
experts in the field of clinical treatment of 17
addiction and experts in the field of research 18
geared at improving and developing new treatments 19
for addictive disorders. 20
All these organizations, representing 21
thousands of members who are experts in the field of 22
addiction, have joined together on this one petition 23
for one reason. We are all concerned that 24
continuing to maintain opiate use disorder as a 25
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qualifying condition for the State's medical 1
cannabis program is putting our patients at greater 2
risk. 3
There is reliable empirical evidence 4
that the use of cannabis can worsen opiate 5
addiction. With the opiate addiction and the 6
overdose epidemic significantly impacting the 7
country and Pennsylvania, it is important that 8
patients have access to the clinically-proven 9
treatments and services that help people recover 10
from addiction. 11
It is also important that they not be 12
given sham treatments or treatments which might 13
worsen their addiction. Ensuring patients have 14
access to all FDA-approved medications to treat 15
opiate use disorder is a critical part of our 16
organized efforts to improve the care and treatment 17
of patients with chronic disease and addiction. 18
Currently there are three categories 19
of FDA-approved medications available in the U.S. 20
for treatment of opiate use disorder, buprenorphine, 21
methadone and naltrexone. Each of these medication 22
categories have been proven to be effective for the 23
treatment of opiate addiction and proven to be cost- 24
effective in reducing drug use and promoting 25
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recovery when used in conjunction with psychosocial 1
services. 2
In a recent study, patients who came 3
to the ER having survived an opiate overdose were 4
followed for one year, to help identify 5
interventions which can protect these patients from 6
dying of a repeated overdose. Prescription of 7
buprenorphine or methadone was associated with 8
reducing all causes of death and opiate-related 9
death. These were literally life-saving 10
medications. Medical marijuana has never been 11
demonstrated for these benefits. 12
When we are talking about treatment of 13
patients with deadly life-threatening illness, offer 14
them sham, unproven treatments puts them in direct 15
harm. This is why we are concerned about allowing 16
opiate use disorder to be a qualifying medical 17
condition for access to the State's medical cannabis 18
program, specifically as the Medical Marijuana 19
Advisory Board has adopted. 20
Jointly, we have - we have been unable 21
to find any evidence of scientific literate showing 22
that cannabis use is beneficial for the treatment of 23
opiate use disorder. There's no reliable empirical 24
data indicating that there's either - that it is 25
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either safe or effective to use cannabis as 1
adjunctive therapy with conventional therapeutic 2
intervention or that cannabis use is associated with 3
remission or recovery from opiate use disorder. 4
Listing cannabis as an alternative for 5
patients for whom conventional therapeutic 6
conventions are contraindicative or ineffective 7
gives - gives cannabis a false validity of being 8
perceived by patients as a safe and effective 9
treatment for opiate use disorder. 10
There's reliable empirical evidence 11
that the use of cannabis can worsen opiate 12
addiction. Cannabis use is common among those in 13
treatment for addiction. Cannabis used by 14
individuals with opiate use disorder has been 15
associated with worse treatment outcomes. 16
Individuals with opiate use disorder 17
at - are at a higher risk for addiction through 18
cannabis. Cannabis can be addictive for upwards of 19
30 to 50 percent of daily users. Cannabis can cause 20
transient psychosis, a break from reality, in just a 21
single episode of use. Risk is especially high with 22
edibles and high-potency cannabis. 23
Our patients are accessing products 24
with greater than 80 percent THC concentration 25
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through State-regulated dispensaries. Cannabis can 1
cause and worsen psychiatric symptoms, especially 2
for individuals vulnerable to mood, anxiety and 3
trauma-related disorders. Many of our opiate use 4
disorder patients are also struggling with these 5
co-occurring conditions. 6
The developing brain in persons age - 7
under the age of 25 is especially vulnerable to the 8
use of cannabis on cognitive performance and 9
increasing the - risk for later development of mood 10
or substance use disorders. 11
Given these concerns, we strongly 12
recommend the Department reverse the decision to add 13
treatment of opiate use disorder as an approved 14
indication. Thank you. 15
CHAIR: Thank you very much. Thank 16
you. Appreciate your comments. 17
All right. So I'm going to go here, 18
because I think the people on the phone are 19
otherwise having - having difficulty. 20
I'd really like to thank all of our 21
speakers for coming to address the Board with your 22
very important comments. Thank you very much. 23
I had some other things that I wanted 24
to talk about. And one of the things is vaping. So 25
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on October 4th I issued a press release urging 1
caution in terms of vaping. At that time we had had 2
- and right now we have one death. I reported one 3
death in - in multiple case of what is now called 4
EVALI or E-cigarette Vaping Associated Lung Injury. 5
It's been called E-V-A-L-I by the CDC. And so these 6
lung injury cases are very serious, life- 7
threatening. And unfortunately, tragically, in some 8
cases fatal. 9
We don't completely know, still, what 10
is making people sick and whether this is due to the 11
products being used or potentially the delivery of 12
those products and the devices. 13
There was a report last week with some 14
preliminary information about Vitamin E acetate. 15
That many of the - the products reported actually in 16
New York had contained Vitamin E acetate used to - 17
actually in the cartridges to cut the THC oil. And 18
they actually had now lung samples from the CDC from 19
- from patients. And all of them, of the 29 of the 20
cases that they looked at had Vitamin E acetate. 21
So Vitamin E, you know, we - we can 22
put it in a cream and rub it on hands and you can 23
even take a Vitamin E capsule. But as - as an oil, 24
it's extremely dangerous and toxic. When it's 25
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vaporized into the lungs, it can cause inflammation. 1
And seems to be associated with the lung injuries 2
that we're seeing, but that is not conclusive. This 3
is 29 patients out of the - the many patients that 4
the CDC had seen. And so it's not conclusive that 5
that's the only addictive that could be - that could 6
be causing, but it certainly is very suggestive. 7
The CDC is continuing to look at this 8
and the Department of Health and our great 9
epidemiologists are looking at this. We are in 10
contact with the CDC and with other states, in terms 11
of these investigations. So this was really the 12
first lead about what might be at least one of the 13
causative agents. 14
So really the - the main products that 15
seem to be associate with these lung injuries and 16
primarily associated, but not exclusively - so it 17
gets complicated - are illegally bought, illegally 18
sourced THC cartridges. So these are cartridges 19
that are made by people in their basements or 20
whatever they do. Some - one - one - some of them 21
have the label Dank, but they're - D-A-N-K - but 22
there are other labels as well. 23
But these are illegal substances. And 24
it seems to be that Vitamin E acetate or maybe other 25
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compounds are being added to them and that is what 1
is causing the vast majority of the - of the lung 2
injury. 3
We - these seem - the CDC, however, is 4
not conclusive that that's all of the cases. There 5
are some cases where it seems that - that people 6
were only using nicotine products and not THC 7
products. 8
Of course you have to remember these 9
are self-report. Meaning that these are people 10
giving that information versus to our researches. 11
They're not in other states and other researches. 12
This is 49 out of 50 states where this has been 13
seen. 14
And so it is possible to question the 15
validity of whether they were buying illegal 16
substances or not. So we don't know. So it seems 17
to be primarily associated. We will continue to 18
work with our federal partners. 19
And so we really want people using 20
vaping products from our dispensaries to safely use 21
these products. Remember in - in our dispensaries, 22
there are medical professionals, such as 23
pharmacists, to educate patients on the safe and 24
effective use of the product. And so we want to 25
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make sure that people are using the right product 1
with the right type of vaping device at the right 2
temperature to enhance safety. 3
You know, there have been some 4
questions whether vaping itself is completely safe 5
or not. And so, you know, we'll continue to - to 6
see what CDC says. But really primarily the main 7
risk is from these illegally-sourced cartridges. 8
And we strongly recommend, in - in the - in the 9
strongest terms I can - I can use, that people do 10
not source and not buy these illegally - illegal 11
cartridges from the street or use them at parties or 12
whatever, because the Vitamin E acetate and other 13
compounds can cause severe issues. 14
People should, if they have any 15
concerns about vaping in terms of our program, talk 16
with your doctor or talk with the pharmacy - 17
pharmacists at the dispensaries. We can assure you 18
that there is - we - we know what is in our 19
cartridges. We know what substances are in the 20
cartridges through the Medical Marijuana Program. 21
We have two sets of laboratory testing 22
on - on - on the products. And we know that there 23
is no Vitamin E acetate in any of the medical 24
marijuana cartridges in our program. So we have 25
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great confidence in that. So there is no Vitamin E 1
acetate. It's been very well-tested and we - we 2
know what's in the cartridges. 3
So as you can see, the physician plays 4
a really important role in terms of - the physician 5
and the pharmacist, but I'm going to concentrate on 6
the physicians in our program. And you know, as 7
part of our program, patients will see a physician, 8
M.D. or D.O., to diagnose whether they have one of 9
the 23 serious medical conditions and whether 10
medical marijuana would be correct for them, and 11
then refer them to a dispensary, where the patients 12
usually will meet with a pharmacist. 13
I want to emphasize, again, as I did 14
at the last meeting, what I consider to be a patient 15
consultation. So I know as a - until five years 16
ago, a practicing physician in adolescent medicine 17
at the Penn State Hershey Medical Center, what goes 18
into a patient's evaluation. You would do a 19
complete history and physical examination. 20
You would review all - all - any 21
pertinent previous medical records. You would 22
review any pertinent laboratories or order 23
laboratories that you would make a diagnosis. And 24
then you would do an assessment and then you would 25
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do a plan or what would be the treatment. 1
That type of patient consultation is 2
what I expect from the physicians in this program. 3
That they will make a - a - the consultation in a 4
manner that's appropriate, to make the medical 5
determination as to the condition and to the 6
treatment. That you establish in the medical record 7
and maintain that record in terms of what was done. 8
That you will consult, which is - really required in 9
the Act - that you will consult the - the 10
Prescription Drug Monitoring Program, to see if the 11
patient is on any substance which could interact or 12
- or change your - your management. 13
That - that you'll receive an informed 14
consent from the patient or possibly from the - from 15
the caregiver, custodial parent, legal guardian or 16
spouse that explains the - either the risks and 17
benefits of medical marijuana. 18
And so, you know, that's what I would 19
do if I - when I was seeing a patient at Penn State 20
Hershey Medical Center in adolescent medicine, to 21
determine a diagnosis and a treatment. And that's 22
what I expect from our physicians. And so I'm a 23
little bit of a broken record, because I said it 24
last time and I'm going to say it again, because I 25
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wanted to emphasize that point. We expect a 1
thorough history, physical examination, review of 2
records, a - an appropriate and thorough 3
consultation from our physicians as they see 4
patients. 5
One of the things that - that we're 6
looking forward to is the continuation of the - of 7
the - the Chapter 20 Program, in terms of - in terms 8
of research into the medical - into the risks and 9
benefits of medical marijuana. And we - we are in 10
the midst of round three, is that correct, of the - 11
of the clinical registrants? 12
We expect that that announcement will 13
be made sometime in the new year, John. Would that 14
be correct? So we're - we're - and - and the three 15
clinical registrants that are working with ACRCs are 16
sort in process of their collaboration. 17
Researchers and physicians and the 18
patients now have 23 conditions. As you know, we 19
voted on a process in the past about how to add new 20
conditions, reduce or add or change conditions. 21
Requesters must submit their application at least 15 22
days prior to the next scheduled meeting to be 23
considered. There are no new conditions that were 24
submitted to be considered at this meeting, so we're 25
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not going to be doing that. 1
In order to have your submission 2
considered for review at the next Medical Marijuana 3
Advisory Board meeting, which is February 13th, you 4
will have to have your application submitted no 5
later than close of business on January 29th, 2020. 6
So the next deadline for people to submit new 7
conditions will be January 29th, 2020 for the Board 8
meeting on February 13th. 9
Is that clear? Did - I made it clear? 10
Please, if you're going to submit new 11
conditions, submit one condition at a time. If you 12
submit three conditions all on the same petition, it 13
makes it for the Medical - for the Medical 14
Subcommittee and the Board and me almost impossible 15
to - to untangle what condition you really are 16
talking about. 17
While I do review the medical 18
literature really carefully, in terms of considering 19
new conditions, if you ask for three conditions all 20
at the same time, it makes it impossible. So if - 21
if a condition is going to be requested to be 22
evaluated, please add one condition at a time. 23
Are there any questions from the Board 24
about what we talked about today? Any questions on 25
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the phone from the Board Members about the vaping, 1
the EVALI or E-cigarette Vaping Associated Lung 2
Injury or - or the new conditions or - physician 3
evaluation? 4
DR. GOLDFARB: No. 5
MS. SHUCKROW: No. 6
CHAIR: Okay. 7
And now we will turn things to John 8
Collins to give us an update about the program. 9
Thank you, John. 10
MR. COLLINS: Yeah. Thank you, 11
Secretary. 12
Good morning, everyone. 13
MEMBER: Good morning. 14
MR. COLLINS: Following up on the 15
Secretary's comments regarding vaporization, 16
labeling, interaction with the medical professionals 17
at our dispensaries. I wanted to cover a couple of 18
talking points pertaining to the importance of that 19
engagement. 20
But first of all, I appreciate the 21
prior guidance, Patrick, for you about engaging law 22
enforcement, getting much more, in terms of 23
inpatients. Appreciate the connections that the PSP 24
is providing me with local law enforcement, to be 25
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able to facilitate that. 1
Also Dr. Peterson, your prior 2
willingness to share is - share with us your work in 3
progress has resulted in some of those labeling 4
changes already. The balance being in the permanent 5
regs, which will be made available for public 6
comment soon. So thank you very much. 7
Regarding vaporization. A couple of 8
things that we're trying to accomplish here that the 9
office feels are absolutely critical to keep 10
patients safe. First of all, we want to ensure that 11
there's compatibility between the vaporization 12
cartridge that's purchased and the supporting 13
device. Meaning cartridges and batteries are 14
designed to work together. That one doesn't 15
necessarily overheat the other for the - for the 16
reasons already stated. 17
In practice, this results in requiring 18
any device purchased from a dispensary for use with 19
a cartridge to be deemed compatible. The most 20
compatible device that can be purchased, in my 21
opinion, is something called a sealed device. This 22
is a component that's sealed. It's also called or 23
referred to as a pen, meaning the cartridge and the 24
battery heating device are one unit. 25
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Stepping back from that would be 1
branded products. So purchasing, as an example, a 2
Standard Farms cartridge with a Standard Farms 3
heating device, called a battery, is preferred. All 4
of those things are available at our dispensaries. 5
It is also very important for the 6
medical professional at the dispensary to educate 7
the patient on that device's safe use. And make 8
sure that they understand the appropriate heat be 9
applied when administering the product. 10
And as has already been pointed out, 11
the importance of labeling and understanding, from 12
the medical professional, what the appropriate 13
amount of this product is to take for a specific 14
disease state and symptomology. 15
And at the end of the day we want to 16
make sure that the patient leaving the dispensary is 17
assured that they are using a compatible device. So 18
a lot of attention is paid on the drug, but we also 19
want to make the connection with the device; just as 20
important or more so with the appropriate use and 21
safe use of the product. 22
In our program we try to accomplish 23
three things, driving a single goal. And that is 24
safe outcomes. Safe outcomes are achieved by safe 25
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access to product, safe product, and safe use of 1
that product. Those three things are critically 2
important to accomplish. 3
We also appreciate the work and our 4
collaborative efforts with the Pennsylvania Cannabis 5
Coalition, the collective that represents about 90 6
percent of our permittees, working with us and 7
finding a pathway forward to implement our good work 8
here as a group. 9
We also appreciate patient feedback. 10
We have had several patient feedback sessions that 11
speak to patient safety and what they like to see 12
about product availability and what they also would 13
like to see on the label. So while we're trying to 14
establish pharma standards and consistencies for 15
labeling, we also want to expand the information 16
that's provided on the label. Because patients are 17
looking for more information, particularly as it 18
relates to terpenes. 19
We also have information that sits in 20
what would be called a package insert, an advisory 21
that probably also should go on the labeling about 22
warnings that you've already pointed out this 23
morning. 24
Regarding our grower/processors and 25
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dispensaries. Last I spoke I thought I could give 1
you an update. Those operational grower/processors 2
that are critical to putting more product in this 3
channel have been cultivating product. Since the 4
last time I was here, two more grower/processors are 5
shipping - actively shipping product, which takes 6
some pressure off availability of certain strains, 7
which our patient population has become very 8
specific about, not just any dry leaf, but a 9
particular strain and particular THC/CBD 10
formulation. 11
So those inventories are continuing to 12
increase. We check them every morning. And I'm 13
pleased to see that more of the menus, which are the 14
online representation of what's available, continue 15
to expand. 16
We had one - one dispensary report 17
that her facilities sell about 30 to 40 pounds of 18
dry leaf a week. That's a significant volume. 19
That's about 16,000 grams a week. So we know 20
patients are actively seeking this product and more 21
inventory continues to be available, including 22
today. 23
We also will see more 24
grower/processors who have been cultivating product, 25
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shipping into the channel over the next three to 1
four weeks. 2
Regarding dispensaries, these are the 3
outlets that everyone is aware of where our patients 4
engage our medical professionals. The last time I 5
was here I mentioned that we had operationalized 60, 6
that's 6-0. So in the course of about three months 7
we've gone from 60 to 72. So we now have 72 8
operational dispensaries. 9
And I'm pleased to report that as of 10
this morning 71 of them are actively dispensing. 11
The latter is located here in Harrisburg and will be 12
coming online soon. 13
Regarding how the program is evolving. 14
There are some important numbers that I think 15
represent the engagement that not only the medical 16
professionals have, but our patient community has, 17
as well as the permittees that are a part - an 18
important part of this program. 19
We have nearly a quarter of a million 20
registrants at this point. That's 225,000 patients 21
that are registered to balance our caregivers. But 22
any given week we have nearly 147,000 active 23
certification holders. These are the people that 24
can go in at any particular time and make a 25
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purchase. What that results in, is on a weekly 1
average we have 65,000 patients visiting our 2
operational dispensaries, purchasing in total about 3
160,000 products. 4
Since the program has been 5
operationalized, and we began dispensing 6
February 15th, 2018, we've totaled two-and-a-half 7
million patient visits, resulting in six-and-a-half 8
million products sold; all tracked through our MJ 9
Freeway electronic tracking system. No small task 10
for everyone involved. 11
In terms of what does this mean 12
financially to the viability of the business? 13
Because we count on viable organizations to be able 14
to sustain what's - what's happening in the market, 15
which is a competitive market, and to be able to 16
provide the necessary service to the patients. 17
Medical professionals are a necessary 18
component of our program. Since the - since the 19
program began dispensing, to date we have a total of 20
$524 million in sales. Those are the global sales, 21
which include purchases at the dispensary and - and 22
sales made by grower/processors to dispensaries. 23
So I'll break it down. $309 million 24
are purchases made by patients and caregivers at our 25
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dispensaries, again $309 million. $215 million 1
represent purchases made by dispensaries from 2
grower/processors. The total being $524 million 3
representing the entire market. 4
It continues to grow, especially at 5
the purchasing front. It continues to grow about 6
two to three percent a week. Likely, sales by 7
grower/processors have exceeded that in some cases 8
in a - in a substantial way, as new cultivations 9
begin ending up in the market, sometimes at 12 to 15 10
percent increase weekly, which indicates product 11
moving through the channel. 12
In terms of what are the disease 13
states looking like? I'll - reference a few things, 14
but the Board has a particular packet in your folder 15
that provides a little bit more specificity. As 16
allowed under the - under the law, you have the 17
information that you have. It's a confidential 18
document. But for the sake of additional notations, 19
I think it's helpful to understand what's driving 20
our serious medical conditions and what's not. 21
All right. Right now pain or pain- 22
related serious medical conditions continue to be 23
the top amount. So if we take pain directly and we 24
add to that cancer, and we add to that neuropathies, 25
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that totals 60 percent. So pain and pain-related 1
symptomology represent and still represent the 2
largest chunk of our serious medical conditions 3
recommended by our more than 1,200 approved 4
practitioners. That leading indicator hasn't really 5
changed since the program started. It's represented 6
in any other - in every other state that has a 7
program like this and it's what we anticipate in 8
seeing here. 9
The Secretary mentioned anxiety. And 10
at the last update I mentioned that we saw a pretty 11
significant uptick in anxiety during the first 12
couple of weeks. That's no longer the case. It had 13
been increasing at a decreasing rate. So currently 14
it represents something around the neighborhood of 15
ten percent. I know externally it - it carries a - 16
a bigger number, but it's - it's about ten percent. 17
So with that, I'll go ahead and move 18
on to the Chapter 20 update piece. 19
As the Secretary pointed out, research 20
is critical, critical to this program, it's critical 21
to the success. Dr. Goldman pointed out a few 22
things that are - are very noteworthy to us 23
regarding where research needs to head. 24
The majority of the research that's 25
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been submitted supports the use of medical 1
marijuana, determining its role with pain and in 2
OUD. That's been mentioned previously at the 3
Research Summit. 4
Also as the Secretary pointed out, 5
sometime during the - first quarter in the new year 6
we would anticipate being able to permit the next 7
round of - of clinical registrants. It's already 8
been mentioned we have three. 9
And just keep in mind that research 10
involves the determination of what that research 11
protocol looks like getting IRB approval. Our 12
patients will be protected and informed via informed 13
consent. These need to be approved by the eight 14
academic clinical research centers, those eight 15
medical programs that are guiding research under 16
this initiative. 17
The next phase is to recruit patients, 18
and to put together studies protocols, and to work 19
with us in terms of framing up an efficient pathway 20
forward and helping those physicians and those 21
institutions that are a part of that research. 22
That's already started. 23
Okay. So it's a little different than 24
a commercial phase, where nothing happens until 25
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something is purchased at the dispensary. This 1
actually starts the other way around. Which means 2
we'll be able to get a good traction on research 3
much sooner than I think most folks would 4
anticipate. 5
I've mentioned training. We have 6
spent a considerable amount of our energy trying to 7
train everyone and anyone in any institution that 8
comes in contact with a patient, whatever that 9
engagement point is. And more recently that's 10
included law enforcement. It's also been expanded 11
to include those managing a patient's parole. 12
And so we're training hundreds of 13
people. In fact, around the first week in January 14
we have the pleasure of presenting and educating 46 15
law-enforcement agencies and we need to do more of 16
that. So we're - we're getting good traction and 17
we're getting those requests and we will fulfill 18
those as they come in. 19
That summarizes, Secretary, my update. 20
And I'll pause if there are questions about anything 21
that I've covered. 22
MS. ROBERTSON: I have a question 23
about the vaping. 24
MR. COLLINS: Sure. 25
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MS. ROBERTSON: So is there any 1
comparison to vaping cartridges in our state 2
compared to what is in other states? 3
CHAIR: So you know, there are - there 4
are 33 states that have medical marijuana and then a 5
number of states that have recreational. They're 6
all different. So I don't know the details in terms 7
of - of the ingredients that are in - in the other 8
state's program. But we know what's in ours. 9
And so, you know, there has been - so 10
we have a lot of confidence in - in your program and 11
the testing of the program that there's no Vitamin E 12
acetate. And John and - and the team know what's in 13
all of the - the vaping cartridges in - in your 14
program. 15
MS. ROBERTSON: So I - I guess my 16
concerns are like someone takes their medical card 17
from Pennsylvania and let's say goes to Washington, 18
D.C. and buys vaping cartridges -. You know, I 19
mean, I know there's no control over that here, but 20
it is a cautionary tale, because just because you 21
get it from dispensary from another place doesn't 22
mean it's as safe as ours. 23
CHAIR: So that's correct. So each 24
state is different, in terms of - of the amount of 25
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the lab testing, in terms of what's in it. I think 1
that - I mean, the Vitamin E acetate was suspected 2
before and it now confirmed in the lungs of 29 3
patients. So I think that you'll find that other 4
states will make sure that there's no Vitamin E 5
acetate in the - in the cartridges that are under 6
their purview. 7
The - the biggest danger that - the 8
biggest danger, in terms of the illegal market, 9
where - both in Pennsylvania and then throughout the 10
country -. You know, unfortunately in states that 11
even have - in some states that even have legal 12
recreational marijuana, there is still an illegal 13
market, particularly California, but in others. 14
Other states have been a little bit more successful 15
in terms of wiping that out. 16
But the vast majoring of cases have 17
been associated with that illegal THC vaping market 18
and the additive solvents, other compounds thrown 19
into the vaping cartridges. Some of which is to cut 20
the THC, so they don't - they don't have to use as 21
much, et cetera. 22
MS. ROBERTSON: It's very hard to 23
tell. I mean, when you - I've seen some of the 24
illegal ones that are packaged. I mean, they look - 25
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they're very -. 1
CHAIR: They're - it's very 2
sophisticated. So we - we - for our program, we 3
strongly recommend that people use only the - the 4
vaping cartridges that are obtained from our 5
dispensaries. If you go to another state, I guess 6
it is better to use something bought from a 7
dispensary then bought illegally or - again, it's 8
not - people don't always buy it. 9
They might be at party and - and 10
handing it around. You don't - you have no idea of 11
what you're getting. And so there is a risk 12
associated with that. There is absolutely a risk. 13
And then there are those other cases 14
that seem to - that CDC hasn't been able to place 15
yet. Meaning it seemed - they - they didn't have 16
any - they say, didn't use any THC at all. They 17
only used nicotine. 18
So it's not clear, was that nicotine 19
that was used from illegal cartridges of nicotine? 20
Did they think - or was bought in a - in a vaping 21
shop or was it bought in a - in a convenience store? 22
So we actually don't know that specificity of data. 23
And so that's why this - this series 24
of conditions - this situation is really complex. 25
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So the best advice we give from Pennsylvania is that 1
for patients who are in our Medical Marijuana 2
Program that they're very careful in terms of where 3
they get vaping cartridges. But that also - I mean, 4
we really want to make sure that the systems work 5
together, that the vaping cartridges and the vaping 6
pens and the - and the batteries and stuff are all - 7
are all consistent with each other and that they use 8
the right temperature. 9
You know, there was some concern that 10
- that if you - if you heat it with a much higher 11
temperature than is recommended, that it can change 12
the chemical composition of the substances, because 13
it's a different chemical reaction. 14
So we really want patients to learn 15
how to use their devices really carefully. We want 16
the pharmacists to educate patients how to use it 17
really carefully. And I think that's the best 18
protection that people can have. And if they have 19
other concerns, talk with your doctor, talk with the 20
- with the pharmacist in our program. 21
And please do not use illegal THC 22
cartridges anywhere in Pennsylvania or the United 23
States. You - you know, people die every day now of 24
this condition. 25
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Did that -? 1
MS. ROBERTSON: Yes. 2
CHAIR: There's still some ambiguity 3
from the data coming out of the CDC. I mean, it's 4
not that they're ambiguous, meaning they don't know 5
everything now. But the - the information last week 6
about Vitamin E acetate was very important, but it - 7
it might not describe the whole situation, meaning 8
there might be other compounds. But we don't know 9
that yet. So you know, we're learning new 10
information every week. 11
MS. ROBERTSON: Thank you. 12
CHAIR: For John or I are - are there 13
other questions from the Board? 14
MR. SHULTZ: Yeah, I have a question. 15
I'm glad to hear that you brought up about more 16
grower/processors shipping product as - as well as 17
even more coming online and shipping within the next 18
weeks, three to four weeks. Because the - the 19
product supply issue has been a - a real tough issue 20
and a - a hardship for a lot of patients. 21
I hear reports of patients driving up 22
to five hours around Pennsylvania looking for 23
product, only to get to a dispensary and find that 24
there's nothing that they need that's available. 25
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A lot of patients have transitioned 1
totally over from pharmaceuticals and other 2
traditional treatments to medical marijuana. Now 3
they're finding a lack of product is disrupting 4
their treatment protocol. And they go back to their 5
doctor to see if they can go back on some pain meds 6
or something else. 7
The doctors are saying no. So it's 8
forcing some patients to go to the black or the gray 9
markets. And as you just mentioned - 10
CHAIR: You don't want to do that. 11
MR. SHULTZ: - there is - there is 12
risks with that whole situation. 13
Can you comment on what can be done, 14
policy or regulatory-wise, so that in the future we 15
aren't faced with similar situations with products, 16
physical -? 17
CHAIR: So I'd like to talk globally 18
and then I'll have John maybe get more in - more - 19
more specifically -. We take this issue really 20
seriously. And you know, hear about it from - from 21
advocates, from the Board, and even from the news 22
about - about that. 23
I think that it is somewhat where the 24
- where the challenge is our own success. Meaning 25
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we have a lot of patients that are - they're a part 1
of the program, which is good. We have a very 2
successful program. 3
I think that some of it is that we 4
added new conditions and so - particularly anxiety 5
disorder, which now is - is leveled off and has 6
plateaued, but - but caused an increase in the 7
number of patients seeking medicine. And it's not a 8
mature market. 9
So one - one thing that John pointed 10
out is that I mean, it's been less than two years 11
that - that this program has been up and running. 12
So we have had a tremendous amount of success, but 13
it's not a mature market, in terms of the grower 14
process - numbers of grower/processors and 15
dispensaries. 16
And then also none of the - none of 17
the ACRCs and the clinical registrants are up and 18
running yet. So that will add a lot of diversity to 19
that. I think that will bring the cost down and 20
have a more stable market. 21
But we take it really seriously. I 22
probably ask John about this every week, about how 23
we're doing. And he kind of keeps me up-to-date. 24
So it isn't that we're neglecting it and it - it 25
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really is - it's very important. So I just wanted 1
to emphasize that. 2
John? 3
MR. COLLINS: Yeah. Thank you, 4
Secretary, and - and thanks for the question. 5
We - we take the feedback very 6
seriously. We - we don't want a patient who depends 7
upon a particular product and strain not to have it 8
available to them. 9
So where we transition to is - you 10
asked for the regulatory perspective, so this 11
response is to you, but it's globally to our 12
permittees as well, Luke. Is product and inventory 13
must be put on the menu immediately. We don't want 14
patients driving. 15
Online reservation systems are 16
encouraged. Some do it very well. We also have 17
been working closely with the Pennsylvania Cannabis 18
Coalition to encourage growers, from a regulatory 19
perspective. 20
And just for clarity for others that 21
may not be aware, that unlike other states or 22
neighboring states, our grower/processors are not 23
limited to how much they can grow. There's no 24
limitation on plants. There's no limitation on 25
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square footage. And the importance of that, I'll 1
illustrate by one our earlier grower/processors 2
coming online and one of the last one coming online 3
and how much they had under canopy, which is how 4
much is growing. 5
The first one coming online had 6
between 7,000 and 10,000 square foot under canopy, 7
which sounds like a lot. It's probably an entire 8
square footage of this building here. The last one 9
that came online went live with 100,000 square feet. 10
There's literally no limit. Our 25 11
grower/processors can behave like 250, if they would 12
double or triple or quadruple their - their square 13
footage. That we're paying very close attention to. 14
We're also paying very close attention 15
to the wholesale price. Although dispensaries 16
legally own the product and can price it at what 17
point they feel is necessary, there's also the 18
transition, Luke, as you know, a product sold by 19
grower/processors to dispensaries. And we're 20
carefully monitoring and have been from the start. 21
All right. So grower/processors, 22
current ones expanding their grow operations, which 23
is allowed under the regulations. Us working closer 24
with the Coalition, to look at more strategic levels 25
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to where we target volume to be a year from now is 1
important. 2
Getting feedback from patients. 3
Although the discussion, I think, has been recently 4
about dry leaf, the feedback I've gotten is, don't 5
forget us, John. We - we want concentrates, we want 6
RSO, we want certain strains. 7
So that's important. So volume and 8
mix are two things that we need to pay very close 9
attention to. Especially as both our patients 10
become much more attuned through their interaction 11
with the medical professionals about what specific 12
strain works for them and their children. 13
And as an aside, we really appreciate 14
- I don't know if Eric Hauser is here in the 15
audience today, but we really appreciate his 16
efforts. Because I talked to patients who have 17
children that are autistic. I have one as well. 18
So knowing that a medical professional 19
like Eric, who's a pharmacist, PharmD, is willing to 20
spend a lot time with a patient and parents on the 21
phone much past the point of sale, go to the credit 22
of the - a medical profession that he's a part of. 23
Others do that as well, which is critical to have 24
that interaction. So in that case someone wasn't 25
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looking for dry leaf. They were looking for a 1
concentrate of a very specific strain. 2
Also being able to call the 3
grower/processor and say to the CEO, your product is 4
noted in four or five instances where it's 5
particularly helpful to patients. So putting your 6
strain out but changing the THC/CBD relationship is 7
a problem for someone that's looking for a 8
particular mix. And he said, I'd be happy to do 9
that now. I wasn't aware. 10
So what - what you're hearing me say, 11
Luke, at this point is, we want to make sure that 12
what patients need, what medical professionals are 13
seeing that they're advising, gets back to the 14
people that are making the product. So we 15
appreciate your participation and others in - in our 16
patient feedback session and we need to do more of 17
it. 18
CHAIR: Other questions from the 19
Board? 20
MS. ROBERTSON: Do - do - is there - 21
is there the ability to put a price cap on - on the 22
product? Because I know in the driving shortage, I 23
mean, the - the prices seem to almost triple in some 24
of the dispensaries. 25
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MR. COLLINS: Well, I'll have the 1
legal folks address what's allowed for under the 2
law. 3
CAROL: Sure. Yes. The statute does 4
provide that the Department may set a price cap. 5
But I think, John, you may have some business end 6
comments on why that may not be necessarily the best 7
thing to do. 8
MR. COLLINS: Yes. There - there - 9
there are other tactics that are more productive. 10
Some of those I just mentioned, which is expanding 11
capacity, expanding invested capital, which is what 12
is happening in Pennsylvania because of the success 13
of its program; leads to more competition. 14
So we've seen pricing come down. I 15
know it's still viewed as expensive. An average 16
purchase through yesterday is $119.76, when 17
purchasing an average of 2 - 2.4 products. So 18
that's about $45, $46 an item, whatever that item 19
is. 20
I know when it's not covered by 21
insurance, it's too much. But it's come down from 22
the high $300s from a year ago. And we're 23
continuing to see it come down every week. 24
One - one thing I think that, Carol, 25
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you're referring to, just this year in my private 1
industry experience, being on the other side of 2
price caps, is what they generally accomplish, and 3
the government uses it now with weight average 4
wholesale pricing for pharma companies, is they 5
actually set price floors, which means everybody 6
rises to that level. 7
So you end up paying more and it's 8
something we need to be very careful about. But 9
we're not ringing our hands over it, Molly. 10
We've seen a couple of instances, one 11
within the last two weeks, where we're on the phone 12
and had the price adjusted immediately. We were 13
told it was an error. The price that was posted was 14
$123,456 a gram. Okay. 15
MS. ROBERTSON: Of dry leaf? 16
MR. COLLINS: And what I heard - yes. 17
What I - what I heard from - from the - from the 18
business owner is trying to send a message. I said, 19
message received, take it down, which they did 20
immediately. 21
And I was told it was just 22
advertisement. I said, yes, of a product price 23
which you have just tripped the switch here. And 24
not our intent, it's down, and in 30 seconds it was 25
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down. How we knew about that was from the patient 1
community. 2
I'm sorry, Molly, you had follow-ups? 3
MS. ROBERTSON: I - I just - the - the 4
dry leaf, because it - the price has literally 5
tripled in a lot of dispensaries. I just - I mean, 6
that really impacts the patients who are already 7
struggling to get the product that they need to get. 8
CHAIR: I think the concern and - and 9
John's more the business person than I am, but I 10
think that the idea is if you set a price X, then - 11
and - and that - and that puts a cap on the price in 12
Philadelphia, actually, all the - all the other ones 13
in the state will rise to X, even if they're lower. 14
MS. ROBERTSON: Yeah. 15
CHAIR: So you'll find that - that it 16
ends up becoming what the price is even if the price 17
in Johnstown was less, now it's going to be X 18
because we set that ceiling. 19
And so from a business perspective I 20
think it's going to be counterproductive. I - I 21
think - again, we take it all really seriously. It 22
- it is not a mature market yet. And - and so I 23
think that as more grower/processors come online and 24
are - and are actually distributing product, as we 25
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get more information from the patients about which 1
strains, et cetera are - and forms are best, as we 2
have more - more and more dispensaries, then you add 3
the - the academic research centers. Each - each 4
clinical registrant can have six dispensaries. So 5
that as the - as the market matures, I think you'll 6
find that the - that the price will come down. 7
MS. ROBERTSON: Yes. I understand 8
that. 9
CHAIR: And - and - yeah. 10
MS. ROBERTSON: But you know, as long 11
there's not going to be statewide shortages again, - 12
CHAIR: Right. 13
MS. ROBERTSON: - you know, that - 14
that - 15
CHAIR: Yep. 16
MS. ROBERTSON: - makes perfect sense. 17
CHAIR: Yep. 18
MS. ROBERTSON: But if we're going to 19
be facing the shortages regularly -. 20
CHAIR: So we watch it really 21
carefully. As a Board Member, if you think there's 22
something we should do, give us a call and we will 23
certainly consider it. 24
MR. SHULTZ: Something that Mr. 25
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Nightingale mentioned, that sort of ties into this. 1
As the - the program matures and we get all of the 2
grower/processors online, if it's anticipated that 3
we need additional grower/processors here in PA, we 4
no longer have the authority to make recommendations 5
on that. 6
Is there any efforts or any ideas on 7
how we can get the authority back to the Board to go 8
forward with recommendations on things like adding 9
grower/processors? 10
CHAIR: My impression, looking at the 11
attorneys, is that would be legislation. 12
But remember, because - as John said, 13
because there's no limitation on how much product a 14
grower/processor produces, you can - I mean, if - if 15
X grower/processor doubles their - their growth, 16
then you essentially have the same thing without 17
having more specific grower/processors. 18
MR. SHULTZ: Yeah. 19
CHAIR: But to add more 20
grower/processors, we would need legislation. 21
MR. COLLINS: Yeah. 22
CHAIR: Yeah. 23
MR. SHULTZ: But even beyond that the 24
Board is kind of in limbo without being able to make 25
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recommendations on expanding the program, making - 1
making changes. And that basically came about 2
through interpretation of Act 16 by the lawyers in 3
the Department of Health. 4
Can we revisit that, take another look 5
at it? As you mentioned the legislative intent 6
seems to be that the Board was to continue. 7
CHAIR: Well, the Board continues. I 8
think that we have a - a robust Board with many 9
different types of participation from advocates, 10
from law enforcement, from the medical community, 11
from, you know, the Department of State, from - I 12
think we have a really active Board. 13
I think that - I mean, I'm always 14
pleased to challenge our attorneys in terms of 15
different things. I do it all the time. But I 16
think that - that we have a robust Board, but 17
there's things we can't do unless the legislature 18
changes. 19
So we do have to follow the - the law 20
and we'd be glad to revisit everything, but I don't 21
think that's going to change. But I'm glad you 22
talked about it. 23
In terms of the number of 24
grower/processors, I think the - the way - I mean, 25
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remember, we - I mean, how many grower/processors 1
are shipping product now? 2
MR. COLLINS: Twelve (12). 3
CHAIR: So we don't even have half of 4
the grower/processors shipping product. So I think 5
that – again, it's not a mature market yet. It has 6
been less than two years. 7
It has been really one of the fastest 8
growing Medical Marijuana Programs in the country, 9
but we don't even have half of the - so before we 10
talk about whether we should reinterpret the law, we 11
don't even have 50 percent of the grower/processors 12
shipping product. 13
So I, you know, I can't - I can't - I 14
can't tell you when that will be, but - you know, 15
and over the next couple of years I think you're 16
going to find that a lot of these problems are going 17
to go away. Because we're going to have 25 18
grower/processors plus 8 clinical registrant 19
grower/processors shipping product. 20
If you add that together, what's that, 21
33? Is my math right? Right, 25 plus 8, 33. See I 22
- I went to medical school. And - and so we have 12 23
now. 24
So I think - I - I mean, I know that 25
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patience is a challenge when we're talking about 1
people and their pain and their symptoms, but 2
there's only so - so fast this program can grow and 3
it's growing as fast as we can get it to grow. 4
MR. SHULTZ: I was just thinking of 5
other issues that we should be working on and would 6
like to work on for the future and I'm just adding 7
grower/processors. Just - 8
CHAIR: Right. 9
MR. SHULTZ: - trying to figure out a 10
way to - to get the legislature to - to change 11
things to -. 12
CHAIR: Sure. So we'd be pleased to 13
talk to you and pleased to engage with the 14
legislature. But for instance, I'll give you an 15
example. You made a recommendation to me to add 16
edibles. 17
MR. SHULTZ: Right. 18
CHAIR: And I agreed with that 19
recommendation. I can't do that. I can't do it. 20
The Board can't do it. I can't do it. 21
Only the legislature can add edibles 22
to the venue. So we have to go back to the 23
legislature and see their ruling. 24
MR. SHULTZ: Yeah. Thank you. 25
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CHAIR: Anything else from the Board? 1
No, we don't take questions from the - 2
from the floor. I'm sorry. But there will be a - 3
an - a patient engagement. 4
Yes? 5
MR. COLLINS: We have - I thought I 6
saw two folks from Lehigh Valley NORMAL sitting 7
there. So I'll - I'll get to them. 8
CHAIR: Right, but some other people 9
had questions. 10
Will - will you be talking to 11
stakeholders afterwards? 12
MR. COLLINS: To some. 13
CHAIR: To some. Okay. 14
MR. SHULTZ: I actually have one 15
question for you, - 16
CHAIR: Sure. 17
MR. SHULTZ: - not necessarily for 18
John. 19
CHAIR: Absolutely. Go for it. 20
MR. SHULTZ: Any word on the 21
replacement for the position left vacant by Tim 22
Keller? 23
CHAIR: We are actively working with 24
the Governor's Office. It's actually the Majority 25
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Leader of the Senate's position. 1
Is that correct? 2
MR. SHULTZ: Minority Senate Leader. 3
CHAIR: Minority Senate Leader. 4
Please - we have reached out. I'm 5
sure, you know, in the midst of everything it's 6
challenging, but feel free to reach out. 7
MR. SHULTZ: I did. 8
CHAIR: Okay. 9
MR. SHULTZ: I even offered them a 10
name. 11
CHAIR: Okay. 12
We'll check again, but - but we have 13
checked. Yes. 14
MR. SHULTZ: Okay. Thank you. 15
One other thing. I have a number of 16
requests from patients, advocates, caregivers to see 17
if these meetings could be live streamed or 18
otherwise broadcast, if that's something that's a 19
possibility? 20
CHAIR: I don't know. We'll ask. I 21
have no idea. But broadcast where? 22
MR. SHULTZ: Through PCN or just live 23
streamed through Facebook or -. 24
CHAIR: I don't know. 25
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MR. SHULTZ: For those who can't make 1
it to the meetings. 2
CHAIR: Thanks. We'll talk about it. 3
Sure. 4
MR. SHULTZ: Okay. 5
That's all I have. 6
CHAIR: Okay. 7
Well, so is there anybody - any other 8
questions or comments or - that the Board would like 9
to make? 10
Any - any comments from the phone? 11
John? 12
MS. SHUCKROW: No. 13
MR. COLLINS: No. 14
CHAIR: Well, thank you very much. 15
I - I just want to say, I - I want to 16
thank the Board for your robust and active 17
participation in the past, now and in the future. 18
I'd like to thank the people who gave their 19
presentations. 20
I'd really like to thank our staff, 21
John, and really all the staff in the Medical 22
Marijuana Office and our - our attorneys for all of 23
their hard work. I think that - when I heard - 24
well, because we had a presentation - a regional 25
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presentation in terms of vaping, these vaping issues 1
and medical marijuana with - with other states in 2
the region. And I really think that we have one of 3
the best Medical Marijuana Programs in the country 4
and that's because we have great staff, we have 5
great attorneys, we have a great Board. And so I 6
thank you very much. 7
May I have a motion to complete the 8
meeting? 9
MS. ROBERTSON: I make the motion. 10
CHAIR: Motion. 11
May I have a second? 12
MS. JOHNSON: Second. 13
CHAIR: All in favor say aye. 14
AYES RESPOND 15
CHAIR: Aye. 16
Any opposed say nay. 17
BOARD MEMBER: Nay. 18
CHAIR: Any - any abstentions? 19
All right. Thank you very much. 20
* * * * * * * * 21
HEARING CONCLUDED AT 11:10 A.M. 22
* * * * * * * * 23
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CERTIFICATE 1
I hereby certify that the foregoing proceedings, 2
hearing held before Chair Levine, was reported by me 3
on 11/13/2019 and that I, Michael G. Sargent, CVR, 4
read this transcript, and that I attest that this 5
transcript is a true and accurate record of the 6
proceeding. 7
Dated the 16th day of December, 2019. 8
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__________________ 12
Michael G. Sargent 13
Certified Verbatim Reporter 14
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